Device recall
Z-0816-2015: EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x…
FDA device recall · Class II · Philips Ultrasound, Inc.
Key facts
| Recall number (Z-number) | Z-0816-2015 |
|---|---|
| Recall event | 69790 |
| Product | EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging. |
| Product code | IYN |
| Recalling firm | Philips Ultrasound, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| 510(k) numbers | K132304 |
| FEI number | 3019216 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database